Decision No. 361-BYT/QD promulgates the Quality Control Regulation for Medicines

Pursuant to …;

NUMBER 361/BYT-QĐ OF APRIL 30, 1990

ISSUING THE REGULATIONS ON DRUG QUALITY CONTROL

 

THE MINISTER OF HEALTH

- Pursuant to Decree No. 153-CP dated October 5, 1961 of the Council of Ministers on the tasks and powers of the Ministry of Health;

- To unify drug quality control procedures;

- At the proposal of the Department of Pharmaceuticals and Medical Equipment;

DECISION:

Article 1

The Minister hereby promulgates the attached Regulations on Drug Quality Control.

Article 2

These Regulations shall take effect from the date of issuance. All previous regulations that conflict with these Regulations are hereby abolished.

Article 3

The Heads of the Office, the Department of Pharmaceuticals and Medical Equipment, the Ministry of Health, the General Director of the Vietnam Pharmaceutical Joint Stock Company, and the Directors of Provincial Health Departments are responsible for implementing this Decision.

REGULATIONS

DRUG QUALITY CONTROL

A- GENERAL PROVISIONS

Article 1

Drug quality control and raw material testing (referred to as drugs) involves determining whether drug quality standards and conditions meet specified requirements.

The purpose of drug quality control is to identify deviations and defects to decide on acceptance or rejection of batches of drugs, find causes and corrective measures for deviations and defects, and evaluate achieved quality levels.

Article 2

All drugs, regardless of origin, must undergo quality control and only those meeting standards or other quality requirements may be produced and marketed.

Article 3

Heads of Departments, relevant management agencies, drug production and trading units; preventive health care and treatment units, especially those directly involved in drug production and supply (including collectives and individuals) are responsible for drug quality and quality control work as prescribed by the State and the Ministry of Health within their jurisdiction.

Article 4

Depending on the scale of operation and inspection requirements, with functions and responsibilities set forth in State and Ministry of Health decisions and regulations, drug production, trading, storage, and usage units must establish corresponding and appropriate quality control organizations. If complex analytical methods cannot be performed due to lack of conditions, they may contract such analyses out to recognized quality control organizations if deemed suitable for requirements, reliability, and desired nature of work.

Article 5

Implement a system of quality control and recognition for laboratories engaged in drug activities. Only recognized laboratories have legal validity for drug quality control.

- AT Central level: inspected and recognized by the Ministry of Health.

- AT Local level: inspected and recognized by the Provincial Health Departments.

Article 6

Some terms used in these Regulations are understood as follows:

a) Product unit: A specific or standardized quantity of material on which measurements are conducted.

b) Population: The entire set of product units under consideration. Depending on the situation, the population can be a batch, several batches, or a production process.

c) Drug batch: A defined quantity of drug products produced during a single cycle and under consistent conditions considered uniform.

d) Sampling method: The procedure for taking or creating samples.

đ) Sample: A number of drug product units taken from the population to provide information about the population and can serve as a basis for decisions regarding the population.

e) Production batch number: Represented by the letters SKS (control number) followed by subsequent numbers, where the first digits indicate the production batch number, and the last four digits represent the month and year of production. It helps identify and trace the entire formation process and quality control of the drug batch if necessary.

g) Batch record: A collection of economic, technical, and quality documentation reflecting and proving the requirements from the formation to completion of the drug batch (excluding packaging records). Each drug batch has its own record.

h) Drug expiration date: The period expressed in months or years on the technical standard or drug label, during which the drug maintains its quality according to the standard.

B- ORGANIZATION, FUNCTION, TASKS AND POWERS REGARDING

DRUG QUALITY CONTROL.

 

, Clause 1, Clause 2 Article 7a of this Regulation.

The drug quality management and control system is organized as follows:

a) National-level drug quality management and control by the Ministry of Health and provincial health departments under the central government.

- Ministry of Health (Department of Pharmaceuticals and Medical Equipment), provincial health departments.

- Institute of Testing and Branch Institutes of Testing.

- Provincial pharmaceutical testing stations organized, functional, and tasked as prescribed by the State and the Ministry of Health.

b) Drug quality control organizations of production, trading, and using units are self-inspection departments of the facilities, directly supervised by the facility directors. Organized, functional, and tasked as prescribed by the State and the Ministry of Health.

C- PROVISIONS IN DRUG QUALITY CONTROL WORK.

Article 8

Inspection objects include drug products and conditions ensuring drug quality.

- Raw materials and auxiliary materials participating in the production process.

- Finished products, semi-finished products, and packaging materials.

Conditions: Technical-quality documentation; production equipment status, measurement, testing, storage, and maintenance; compliance with technological discipline; storage, packaging, transportation regulations, and implementation of related quality assurance and improvement systems.

Article 9

The basis for drug quality control depends on the inspection object, including:

- Technical standards as prescribed by the Ministry of Health.

- Formulas and technical processes.

- Approved product samples.

- Economic contracts (not conflicting with technical standards and regulations).

Article 10

The content of drug quality control depends on the functions and tasks of the drug quality control organization as stipulated in Article 7.

- For national-level drug quality control organizations of the Ministry: Implementation of standards, measurement, and quality control regulations; testing; inspection of related quality control systems; periodic or random sampling inspections; classification and grading of quality levels.

- For the quality control department: Check the preparation for production and circulation; the quality of raw materials, auxiliary materials, materials, imported products, the production and circulation process (each stage); check the acceptance and factory release.

D- OTHER PROVISIONS

 

Article 11

Medicines are classified into two categories based on quality: Meeting standards and not meeting standards.

a) Meeting standards:

Level A: Fully meets the standards and the content of quality inspection as stipulated in Article 10.

Level B: Has deviations or defects but does not affect the efficacy of the medicine and safety for users, which can be tolerated and accepted for use.

b) Not meeting standards: Does not meet the standards as well as other technical-quality regulations, with obvious and serious deviations or defects - shall not be circulated.

Article 12

The quality classification of medicines is based on the percentage of batches of products that meet the standards (Level A, B) and those that do not meet the standards within the planned periodic review (monthly, six-monthly, and annually) according to the batch product regulations and batch product records.

Article 13

When transferring medicines, there must be a test report attached.

Article 14

Extend the use period of medicines that have exceeded their expiration date if they are still usable upon assessment. When extending the use period, the following must be done:

- Re-test the medicine (conducted by the Institute of Testing, Branch Testing Institute, or authorized testing facility).

- If necessary, re-test the pharmacological effect.

- Provide a full report: quantity, production batch number, quality status.

Central extension of use is decided by the Ministry of Health, while local extension of use is decided by authorized facilities; otherwise, an application for extension of use must be submitted to the Ministry of Health.

Article 15

Apply tolerance for medicines with minor deviations or defects that do not affect the efficacy of the medicine and are not harmful to users. When applying tolerance, the following must be done:

- Submit a request form: Name of the medicine, quantity, production batch number, criteria for tolerance requested.

- Reason for requesting tolerance, supporting documentation.

- Test report of the batch of medicine.

The level that permits circulation of the medicine also permits tolerance.

Article 16

AApply the recall procedure for medicines that are currently circulating and fail quality checks.

All units (including individuals and groups) upon discovering non-compliant medicines must self-recall or comply with recall orders and must:

- Prepare a recall record: Name of the medicine, quantity, production batch number, quality status before, during, and after recall.

- Develop a detailed account of the consequences caused by the batch of medicine and the reasons.

- Report the recall to the superior management authority.

Recall order: at the central level issued by the Department of Medicine - Medical Equipment; at the local level issued by the Provincial/Municipal Health Department.

Article 17

Apply penalties for violations of medicine quality according to current national and Ministry of Health regulations.

 

E- IMPLEMENTATION PROVISIONS

 

Article 18

The quality control regulations apply to all units and agencies related to medicines, including entities outside the health sector engaged in pharmaceutical activities; They must guide and implement state and Ministry of Health regulations on quality control, establish and issue quality control regulations suitable to specific local conditions and organizational guidance to ensure quality control implementation at various levels under their jurisdiction.